Studies of the Prevention of Atrial Fibrillation by ALA

Atrial Fibrillation Clinical Trial

Official title:

Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00410839
• Other study ID #: 99-04 (CPPRB Bordeaux B)
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 12, 2006
• Last updated: December 12, 2006
• Start date: June 1999
• Est. completion date: June 2003

Study information

• Verified date: August 2004
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Generale de la Sante, Ministere de la sante
• Study type: Interventional

Clinical Trial Summary

An alpha-linolenic acid (ALA) rich diet in the Lyon Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since then, there has been a growing interest in ALA as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic effects, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Heart Study.

Description:

Objective: We determined the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia.

Design: Randomized parallel design efficacy study. Setting: Three university hospital centers in the Bordeaux region, France. Patients: 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol.

Intervention: A canola margarine and oil together with a Mediterranean diet (ALA ω-3, 1.4 g/d) versus a conventional diet (control), with a one year follow-up.

Main outcome measure: Length of time to first recurrence of atrial fibrillation.

Significance: If ALA is antiarrhythmic this action may explain its cardioprotective effect in clinical trials and cohort studies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

• patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.

Exclusion Criteria:

• included patients who were unable to receive electrocardioversion or those who were already enrolled in another trial

• patients who were unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements

• patients with clinically significant cardiac disease, advanced heart failure, cardiac cachexia, thyroid disease, treated or untreated, clinically significant hepatic or renal disease or a history of malignant disease or alcohol abuse were not included

• Taking ALA rich foods or recording intakes of ALA >2g/d on the control diet or reporting using <1g/d on the ALA diet was considered a major deviation from the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diet Therapy

Intervention

Procedure:
• ALA rich diet

Locations

Country	Name	City	State
France	Emile Roux Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (1)

de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9. Erratum in: Lancet 1995 Mar 18;345(8951):738. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of recurrence and length of time to first recurrence of atrial fibrillation.